Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Arthritis (1723)
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Event Date 01/09/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Unique identifier (udi) number: (b)(4).Concomitant medical products: multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2019 - 00236, 3002806535 - 2019 - 00237.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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Revision due to disease progression on lateral knee.
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Manufacturer Narrative
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(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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It was reported that the patient underwent initial knee surgery.Subsequently, the patient was revised to tka due to arthritis progression to lateral side.
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Search Alerts/Recalls
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